MODULE 6 DATA QUALITY & CLEANSING. CRIS Manual of Operations April

Transcription

1 MODULE 6 DATA QUALITY & CLEANSING April

2 Table of Contents MODULE 6 1 DATA QUALITY & CLEANSING 1 Section 1 - Overview 3 Section 2 Logging Transmittal Forms 4 Section 3 Cleaning Data 7 Section 4 Updating Logs 9 Section 5 Quality Assurance 11 April

3 Section 1 - Overview The role of quality management is to oversee the quality process. The following module will cover the data quality and cleansing process and will reference the data quality plan found in the Appendix as well as other CRIS modules. The sections of this guide will outline the logging process and illustrate how data are cleaned when errors are discovered. Lastly, the auditing process will be defined. The software log in and edit process is outlined within the individual software modules. The edit rights are given to a limited number of system administrators and data quality staff. April

4 Section 2 Logging Transmittal Forms The Quality Manager logs each transmittal form as it reaches its final stage in the quality process. Once the forms are processed by the quality coordinator, the transmittal forms, corresponding paperwork, and the participant s chart are submitted to the Quality Manager for logging and correcting when necessary. The manager maintains a Master Event Management Spreadsheet which includes the following columns: Most recent date chart was checked-in Participant identification (PID) numbers for each participant and familial ties associated with each PID Participant type Assigned data collector Columns representing the flow of each participant from screener through each event, including withdrawals, corresponding dates, and the data collector who conducted the event. Each event is distinguished by a different color and includes pertinent information for each event. In this example, a 1 represents a yes or completed and a 0 represents a no or not completed. Cells are left blank if the information was not available or there was no indication that the portion of the event was either complete or not completed. A -7 represents data that are known to be missing. An NA is used when the information is not applicable to that participant. The mother s event documentation is logged using the mother s PID from consent through the birth event. Starting at the three month visit, the logging occurs using the baby s PID. Father s event documentation is logged using the father s PID. April

5 April Figur e A

6 April

7 Section 3 Cleaning Data For each issue, problem, or circumstance, the quality team determines whether it requires editing or noting and flags the corresponding transmittal form for the Quality Manager. The Quality Manager is the only approved editor. To establish a history of changes that are made and determine whether trends are occurring, logging issues and edits is an important, necessary step. The manager maintains a Quality Assurance Issue Log which includes the following columns: The date the issue was discovered or the date the edit was made. If these two dates are not the same, make a note of this in your spreadsheet. The corresponding PID. The data collector that conducted the event in which the issue was discovered. The type of instrument or event that requires the edit or where the issue was discovered. The general issue that was found. (e.g. computer error, skip pattern error, participant error, etc.) The specific issue. For edits that are made or issues that are found, this column is used to identify which specific question on the instrument that the issue was found or a specific description of the issue if it was not tied to an instrument. For example, if a skip pattern issue was discovered in an instrument, the specific issue might read Q2-6 were skipped by the data collector. This column will also include what edits, if any, were made. The initials of the person who made the edit or noted the issue. The initials of the Study Director after the approval has been made and signed off on a hard copy. When edits or issues are logged, the Quality Manager initials the appropriate column and prints the form to allow for the Study Director to sign-off on the approved edits. This hard copy is signed and dated by the director, returned to the Quality Manager and filed. Once the hard copy is filed, the Quality Manager fills in the appropriate approval column on the spreadsheet with the Study Director s initials. Once the spreadsheet has been printed, signed, approved, and logged, the completed row is considered closed. Below is an example of the issue log. Edit approval by the Study Director is mandatory. If an edit is not approved, the manager should have documented the change in enough detail that he or she is able to reverse the edit that was previously made; hence the importance of the detailed description of the edit in the specific issue column. The reversal of the edit should also be documented in the issue log. Edits should never be made that are not able to be reversed without prior approval of the Study Director. Any issues concerning consent or protocol violations should immediately be brought to the Study Director s attention and addressed accordingly. April

8 April

9 Section 4 Updating Logs In addition to the Master Event Management Spreadsheet and Quality Assurance Issue Log, the Quality Manager also updates and/or verifies two other logs: the Participant Identification Log and the Prediction Log. The Participant Identification Log (PID Log) is updated every time there is a change to the participant s information or a participant is newly enrolled. A change in information might include learning the baby s name after birth, the marriage of a participant and subsequent name change, or newly enrolling a participant. As shown below in Figure C, the PID Log includes each participant s name, PID, and familial linked PIDs. This log provides a quick reference of the study participants for the site and is one of the few locations the participants names and identification number are found together. For security purposes, this file needs to have restricted access. The corresponding PID and name is verified by the Quality Manager each time a transmittal form is processed. This is done by referring to the participant s consent documentation in the chart. Name Person ID Mother's PID (if baby) Mother's PID (if father) April

10 The Prediction Log is used by the Quality Manager to predict or estimate the number of visits to anticipate over a certain period of time (e.g. week, month, year). This will enable the center to ensure that all events are being conducted in a timely manner and ensure that no events are missed. The log is a worksheet attached to the Master Event Management spreadsheet and draws information from the Master Event Management spreadsheet in order to calculate time windows that an event should be conducted. In addition to the event windows being calculated, a column is also added that counts down the number of days until the window is closed. This is formulated to auto calculate within Excel. When the number of days until the window closes reaches 14 days, the cell is automatically highlighted red to notify the Quality Manager that the window is coming to a close. Some events, such as the birth visit, cannot be predicted. However, the center should have a good idea of the number of birth visits based on the mothers due dates. Other events, starting at the 3 month visit are all calculated based on the baby s date of birth. The Quality Manager maintains the Prediction Log which includes the following columns: The participant s PID Participant s date of consent PV1 Date PV2 Date, if available Due Date Actual Delivery Date Necessary columns for each event that are able to be predicted based on the previous columns (i.e. open window date, close window date, number of days of window, number of days until window closes based on today s date, etc.) April

11 Section 5 Quality Assurance A systematic audit is encouraged and includes portions of the entire process, from data collection to data submission. Approximately 10-15% of all processes require a thorough audit. The percentage should be determined based on the center s participant volume and Study Director s guidance. Data Collection Audit Approximately 10% of each data collector s visits are monitored for quality assurance. Refer to the Event Validation section of the Quality Plan for specific instructions. Validations associated with field events and phone events will primarily be conducted by the Field Staff Supervisor. In addition the Quality Manager, Regulatory Manager, and Study Director are also authorized to conduct these audits. Data Submission Audit Because the quality coordinator reviews all of the data submitted post collection, the submission of all data is 100% audited. Refer to the quality coordinator s duties in the Quality Plan. Transmittal Form Processing Audit The transmittal form process is conducted by the quality coordinator and then submitted to the Quality Manager for additional recording purposes. During this process, the quality coordinator s work is 100% audited by the Quality Manager. To review this process, please refer to the previous sections within this module as well as the duties of the Quality Manager in the Quality Plan. Overall Audit In order to ensure that files are flowing through the quality process completely and accurately, the Quality Manager needs to conduct an overall audit. Depending on the site s flow volume (i.e. number of visits being conducted on a weekly or monthly basis), the frequency of this audit should be determined by the Study Director and the quality team. Approximately 10-15% of events should be randomly selected based on the amount of time determined (e.g. once a month or once a week). Those charts should then be pulled. Once the charts are selected and pulled, the Quality Manager will track each chart from the data submission portion of the quality plan through the filing of the charts. This should be a detailed check of the charts contents, the logging of the charts from the quality coordinator and manager, the scanning process, and ultimately the proper filing of the chart. The scanning process can be found in the Quality Plan. Errors should be documented and then edited using the editing process outlined in this module. Also, it is necessary to note that the errors were discovered during the audit. This process allows the quality team to assess where fundamental quality issues lie and formulate a protocol to better ensure the overall accuracy of the quality process. April